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NCT03506373 · OUTCOME

Complete Response Rate (CR)

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2026-05-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

Complete response rate to be defined as an objective status of CR at any time, where confirmation of the complete response status is required on two consecutive evaluations with a second immunofixation before calling the patient a CR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.

Groups in this outcome

Treatment (Ixazomib Citrate, Ibrutinib)

Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. \> \> Ibrutinib: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pharmacodynamic Study: Correlative studies \> \> Pharmacokinetic Study: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Ixazomib Citrate, Ibrutinib)21

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Ibrutinib)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Complete response rate to be defined as an objective status of CR at any time, where confirmation of the complete response status is required on two consecutive evaluations with a second immunofixation before calling the patient a CR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. \> \> Ibrutinib: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pharmacodynamic Study: Correlative studies \> \> Pharmacokinetic Study: Correlative studies
    id
    OG000
    title
    Treatment (Ixazomib Citrate, Ibrutinib)
param Type
NUMBER
reporting Status
POSTED
time Frame
4 years
title
Complete Response Rate (CR)
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice